# K070734: Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A, DZ168A-Cal, DZ168A-Con

- Pathway: 510(k) (Special)
- Applicant: Diazyme Laboratories
- Decided: Apr 9, 2007 after 24 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092911: Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control Kit, Model DZ168B-Con, Smart HBAC1C Analyzer (2010), 1 descendant of its own
- K160762: Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set (2016), 0 descendants of its own
- K111664: Diazyme Cystatin C Poc Test Kit (2012), 0 descendants of its own

## Recalls of this device
- Aug 22, 2008 · Not classified · Z-0482-2009: Internal studies observed occasional unexpected outlier results in whole blood samples tested for Hemoglobin A1c using the EZA1c reagent on the ACE or ACE Alera clinical chemistry systems.

## Indications for use
Diazyme Direct Enzymatic Hemoglobin Ale (glycated hemoglobin Ale; Ale; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin Ale is a valuable indicator for long-term diabetic control. For in-vitro diagnostic use only.

Source page: https://510kreport.com/device/K070734
Methodology: https://510kreport.com/methodology